BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYFRECATOR 2000

    MDR report key: 25137327 · Received May 11, 2026

    Report

    Report Number
    3007305485-2026-00111
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    April 20, 2026
    Report Date
    May 8, 2026
    Manufacturer
    CONMED
    Product Code
    GEI
    PMA / PMN Number
    K970493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THE 7-900-115, HYFRECATOR 2000, 115V/50-60HZ DEVICE WAS USED IN AN UNNAMED PROCEDURE ON (B)(6) 2026, AND "ITEM 7-900-115 WHEN IN USE ON A PATIENT SPARKED AND CAUSED A SMALL BURN TO THE PATIENT. PATIENT NO FURTHER CARE WAS NEEDED.¿. THE CUSTOMER WAS UNABLE TO PROVIDE FURTHER INFORMATION TO DATE. THERE WAS NO REPORT OF FLAME OR ARCING. THERE WAS NO REPORT OF MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43748 HYFRECATOR 2000 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED

    Patients

    Seq Age Sex Outcome Treatment
    1